Azur Detachable Helical HydroCoil 45-480410Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00810170017902), received between Sep 27, 2016 and Jul 15, 2026 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2026Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25830032 ↗
• InjuryAug 22, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A HEPATIC ARTERY EMBOLIZATION PROCEDURE, THE EMBOLIZATION COIL PREMATURELY DETACHED WITH HALF OF THE COIL OUTSIDE THE CATHETER. THE PHYSICIAN ATTEMPTED TO PUSH THE COIL IN INTENDED SITE WITH USE OF GUIDEWIRE AND COIL PUSHER WITH NO SUCCESS. THE COIL WAS RETRIEVED BY PUSHING THE 2.5FR MICROCATHETER OVER ABOUT 80% AND THEN PULLED OUT THROUGH THE MOTHER CATHETER WITH ASPIRATION (WITH EVERYTHING CROSSED). THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20027189 ↗
• MalfunctionMar 28, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE COIL WAS RELEASED SUDDENLY INSIDE THE PATIENT WITHOUT ACTIVATING THE HANDLE BEFORE ARRIVING AT THE EXPECTED LOCATION. THE COIL WAS REMOVED AND REPLACED WITH ANOTHER COIL. THERE WAS NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19001112 ↗
• MalfunctionDec 19, 2023Component Missing; Component Missing

  IT WAS REPORTED, UPON OPENING THE COIL DURING THE CASE, THERE WAS NOT A COIL ON THE PUSHER WIRE. THERE WAS NO PATIENT INTERACTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18358477 ↗
• MalfunctionDec 19, 2023Component Missing; Component Missing

  IT WAS REPORTED, UPON OPENING THE COIL DURING THE CASE, THERE WAS NOT A COIL ON THE PUSHER WIRE. THERE WAS NO PATIENT INTERACTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18358476 ↗
• MalfunctionSep 5, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT AN EMBOLIZATION COIL IMPLANT DETACHED UNEXPECTEDLY WITH THE LUMEN OF A MICROCATHETER. THE COIL WAS NOT USED. THERE WAS NO PATIENT INJURY OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17686539 ↗
• MalfunctionJun 24, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT, DURING MANIPULATION OF THE EMBOLIZATION COIL, IT DETACHED WITHIN THE CATHETER. THE COIL COULD NOT BE ADVANCE FROM THE CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12062089 ↗
• MalfunctionFeb 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT, THE EMBOLIZATION COIL IMPLANT DETACHED. THE IMPLANT WAS PUSHED INTO POSITION. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11382723 ↗
• InjuryMar 2, 2018Detachment Of Device Component; Device-Device Incompatibility; Detachment Of Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT AFTER ATTEMPTING TO POSITION AN EMBOLIZATION COIL IN THE ARTERIOVENOUS MALFORMATION, THE PHYSICIAN PASSED A WIRE DOWN THE LEFT ANTERIOR DESCENDING ARTERY. RESISTANCE WAS ENCOUNTERED WHEN ATTEMPTING TO ADVANCE THE COIL IN THE MICROCATHETER. THE PUSHER BROKE 1CM PROXIMAL TO THE COIL ATTACHMENT POINT. THE DETACHED COIL WAS SUCCESSFULLY RETRIEVED WITH A SNARE DEVICE. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7311572 ↗
• MalfunctionJan 5, 2018Detachment Of Device Component; Device-Device Incompatibility; Detachment Of Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE COIL. DURING THE REMOVAL ATTEMPT, THE COIL DETACHED IN THE MICROCATHETER. BOTH SEGMENTS OF THE COIL WERE REMOVED TOGETHER WITH THE MICROCATHETER FROM THE PATIENT. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7170288 ↗
• MalfunctionSep 28, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT DURING AN EMBOLIZATION PROCEDURE, THE COIL UNEXPECTEDLY DETACHED IN THE MICROCATHETER. BOTH SEGMENTS OF THE COIL WERE REMOVED FROM THE PATIENT. THERE WAS NO REPORTED INTERVENTION OR PATIENT INJURY. THE PATIENT'S STATUS IS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6903098 ↗
• MalfunctionMay 16, 2017Detachment Of Device Component; Device-Device Incompatibility; Detachment Of Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT AFTER PLACEMENT OF AN EMBOLIZATION COIL IN AN ANEURYSM LOCATED AT THE LOWER POLAR SPLENIC BRANCH, RESISTANCE AND FRICTION WERE ENCOUNTERED WITHIN THE MICROCATHETER. DURING AN ATTEMPT TO REPOSITION, THE COIL UNEXPECTEDLY DETACHED. THERE WAS NO REPORTED INTERVENTION. THE COIL REMAINS IMPLANTED IN THE ANEURYSM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6568832 ↗
• MalfunctionMar 1, 2017Detachment Of Device Component; Device-Device Incompatibility; Detachment Of Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT COIL EMBOLIZATION TREATMENT WAS ATTEMPTED ON A SPLENIC ARTERY ANEURYSM. DURING ADVANCEMENT OF THE COIL IN THE CATHETER, RESISTANCE WAS ENCOUNTERED AND THE COIL UNEXPECTEDLY DETACHED IN THE CATHETER BEFORE THE COIL HAD EXITED INTO THE PATIENT. THE ENTIRE COIL WAS REMOVED TOGETHER WITH THE CATHETER WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6370959 ↗
• MalfunctionSep 27, 2016Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT DURING AN ATTEMPT TO PLACE A COIL IN THE GASTRODUODENAL ARTERY, THE COIL DISENGAGED AND GOT STUCK IN THE MICROCATHETER. THE COIL AND THE MICROCATHETER WERE REMOVED TOGETHER, AND ANOTHER MICROCATHETER AND COILS WERE USED FOR THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5982023 ↗